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Clinical Trials/NCT03387696
NCT03387696
Completed
Not Applicable

Mucormycosis in ICU: A French Multicenter Cohort Study

University Hospital, Grenoble21 sites in 1 country74 target enrollmentSeptember 8, 2017
ConditionsMucormycosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mucormycosis
Sponsor
University Hospital, Grenoble
Enrollment
74
Locations
21
Primary Endpoint
Mortality at Day 28
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns.

ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of patients with mucormycosis admitted in ICU at day-28 after admission. This study will also try also to describe the epidemiology of patients admitted in ICU.

Detailed Description

Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns. The incidence of Mucormycosis is currently increasing reaching 7% of invasive fungal infections in some immunocompromised patients. Because of its aggressive nature, Mucormycosis is associated with poor survival and high morbidity ; mortality is estimated between 16% and 64% according to different retrospective studies. No study has ever evaluated prognosis of patients with mucormycosis admitted in intensive care units (ICU). ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of patients with mucormycosis admitted in ICU at day-28 after admission. This study will also try also to describe the epidemiology of patients admitted in ICU and to evaluate the prognosis of different subgroups of patients according to : * their clinical characteristics : demographic characteristics, clinical conditions and factors of immunosuppression * the characteristics of the fungal infection * the treatment strategy * the severity of the initial illness, evaluated by severity scores Twenty-one French ICU are currently including more than 45 patients.

Registry
clinicaltrials.gov
Start Date
September 8, 2017
End Date
June 1, 2018
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • confirmed or suspected mucormycosis, based on international definition from EORTC/MSG
  • patient hospitalized in intensive care unit during the 2008-2016 period
  • Zygomycosis identification in at least 2 solids organs or identification in hemoculture

Exclusion Criteria

  • Age under 18 years old
  • Patient under the law

Outcomes

Primary Outcomes

Mortality at Day 28

Time Frame: up to 28 days

Mortality at Day 28 after ICU admission

Secondary Outcomes

  • Length stay in ICU(up to 28 days)
  • Length stay of hospitalization(up to 90 days)
  • Mortality during the hospitalization(up to 90 days)
  • Mortality at Day 90(up to 90 days)
  • Mortality during the ICU stage(up to 28 days)
  • Prognostic criteria(up to 28 days)

Study Sites (21)

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